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Abstract:

The invention relates to a tip cap assembly for closing a distal opening
of a receptacle like a syringe body or a tube in a sealed manner, and to
a method for producing the tip cap. A cap assembly according to the
invention comprises a frangible tip of a receptacle, preferably a
pre-filled receptacle. An upper portion of the tip closes the receptacle
respectively a lower tip portion comprising a passage as known from the
state of the art. Hence, the receptacle is reliably sealed to prevent
contamination or loss of the medication. Compared with the state of the
art, a receptacle has a more effectively sealed tip. It is necessary to
break the upper tip portion away in order to open the receptacle. A cap
element protects the tip on one side. On the other side, unscrewing the
cap breaks the upper portion away without hurting a person.

Claims:

1-21. (canceled)

22. A cap assembly comprising a frangible tip of a receptacle, a
fastening ring and a cap element attached to the fastening ring by an
internal and at least one of an external thread and a bayonet joint,
wherein, the fastening ring is attached at the receptacle or a lower tip
portion of the tip by an annular protrusion and wherein, the cap element
comprises a plurality of locking tabs, wherein in the closed position of
the cap assembly the locking tabs are enclosed with a form fit by locking
recesses provided by projecting locking elements.

23. The cap assembly according to claim 22, wherein the receptacle is a
syringe or a tube.

24. The cap assembly according to claim 22, wherein the tip is composed
of an upper tip portion, a lower tip portion and a predetermined breaking
point between the upper and the lower tip portion.

25. The cap assembly according to claim 22, wherein the lower tip portion
takes the form of a hollow needle comprising a canal.

26. The cap assembly according to claim 24, wherein a predetermined
breaking point is concave and borders on the upper angular edge of the
lower tip portion of the frangible tip.

27. The cap assembly according to claim 22, wherein the lower tip portion
of the tip of the cap assembly comprises a plurality of projecting
locking elements adjacent to the body of the receptacle for attaching the
fastening ring either to the receptacle or to the lower tip portion.

28. The cap assembly according to claim 27, wherein the projecting
locking elements and the lower tip portion are made in one piece.

29. The cap assembly according to claim 27, wherein the projecting
locking elements provide a plurality of clearances for attaching the
fastening ring to the receptacle or to the lower tip portion.

30. The cap assembly according to claim 22, wherein the lower tip portion
of the tip further comprises a plurality of projecting locking elements
which are so designed that it is possible to fasten the fastening ring to
the receptacle by a snapping action.

31. The cap assembly of claim 22, wherein the lower tip portion of the
tip comprises a plurality of projecting locking elements which are so
designed that it is not possible to unfasten the fastening ring attached
at the receptacle or at the lower tip portion without causing damage.

32. The cap assembly according to claim 22, wherein the annular
protrusion and the fastening ring are made in one piece.

33. The cap assembly according to claim 22, wherein the lower tip portion
of the tip is conical.

34. The cap assembly according to claim 33, wherein the locking tabs and
the corresponding locking recesses or the projecting locking elements are
so designed that it is not possible to screw the cap element on the tip.

35. The cap assembly according to claim 22, wherein a cylinder-like gap
remains between the cap element and an upper tip portion extending to a
seal on one side and to an opening on the other side.

36. The cap assembly according to claim 22, wherein a cap element
comprises a cylinder-like recess surrounding the upper tip portion of the
tip.

37. The cap assembly according to claim 22, wherein the cap assembly is
composed of an artificial material.

38. The cap assembly according to claim 22, wherein the cap assembly
further comprises a transparent fastening ring.

39. The cap assembly according to claim 22, wherein the fastening ring
and the cap element comprise visible signs which are in line.

40. The cap assembly according to claim 22, wherein the cap assembly
comprises a sealed cavity which prevents contamination of a lower tip
portion as well as the upper edge of the lower tip portion.

41. A receptacle comprising the cap assembly of claim 22, wherein the
receptacle is prefilled with a medical preparation.

42. A method for providing a cap assembly according to one of the
preceding claims comprising: (a) screwing a cap element which comprises a
plurality of locking tabs, onto a fastening ring, and (b) pushing the
fastening ring against an end of a body of a receptacle comprising a
frangible tip thereby providing a snap-in connection between projecting
locking elements of the frangible tip and an annular protrusion of the
fastening ring and a form fit connection between the projecting locking
elements and the locking tabs.

Description:

[0001] The invention relates to a tip cap assembly for closing a distal
opening of a receptacle like a syringe body or a tube in a sealed manner,
and to a method for producing the tip cap.

[0002] Conventional syringes each include a barrel having an open proximal
end and an opposed distal. A cylindrical wall extends between the ends
and defines a substance retaining chamber. An elongate tip projects from
the distal end of the syringe barrel and includes a narrow passage which
communicates with the substance retaining chamber of the barrel. A
plunger may be inserted into the open proximal end of the syringe barrel
for sliding fluid-tight engagement with the cylindrical chamber wall.
Sliding movement of the plunger in a distal direction urges fluid in the
chamber through the passage in the tip. Conversely, sliding movement of
the plunger in a proximal direction draws fluid through the passage in
the tip and into the chamber of the syringe barrel.

[0003] Conventional syringe barrels typically are made of plastic or
glass. Glass exhibits lower gas transmissivity than plastic. Thus, glass
syringe barrels are used for medications that are particularly
susceptible to interaction with ambient gases. Glass syringe barrels also
are preferably used for medications that are pre-filled into the syringe
barrel and stored for a considerable period of time prior to use.

[0004] Such syringes may further include a needle assembly with a needle
cannula having a proximal end, a pointed distal end and a lumen extending
axially therethrough. The needle assembly also includes a hub which is
engage able with mounting means on the syringe barrel for selectively
placing the lumen of the needle cannula in fluid communication with the
passage through the tip of the syringe barrel.

[0005] One prior mounting means includes a luer collar disposed in spaced
concentric relationship around the tip of the syringe barrel. The luer
collar includes an array of threads for threaded engagement with
corresponding structure on the hub of the needle. For example, the luer
collar may include an array of internal threads which are engageable with
projections extending outwardly from the hub of the needle cannula.
Syringe barrels formed from plastic may have the luer collar unitarily
molded therewith. However, glass syringe barrels may not be easily formed
with a unitary luer collar. Thus, glass syringe barrels and some plastic
syringe barrels may have a separately formed luer collar securely mounted
to the tip of the syringe barrel. The luer collar may rely upon a slip
fit engagement, a snap fit or other such secure mounting engagement
around the tip of the syringe barrel.

[0006] Medications that are pre-filled into a syringe barrel must be
sealed to prevent contamination or loss of the medication. Seals also
prevent health care workers from being needlessly exposed to medications.
The prior devices have included stoppers or closures mounted over the tip
at the distal end of the syringe barrel to prevent leakage and to avoid
contamination of the medication. Prior tip caps have been formed from
elastomeric material frictionally and/or resiliently retained in
engagement with the tip of the prior syringe barrel. The prior tip cap
may be removed from the syringe tip shortly prior to usage of the
syringe. The hub of the needle assembly may then be securely engaged with
the luer collar or other mounting means adjacent the exposed tip of the
syringe barrel. For example, the needle hub may be threadedly engaged
within the luer collar such that the lumen of the prior needle cannula
communicates with the exposed tip of the prior syringe barrel.

[0007] Prior elastomeric tip caps on the ends of pre-filled syringe
barrels generally perform well. However, the resiliently and/or
frictionally engaged type tip cap may be accidentally disengaged from the
tip of the syringe barrel in response to inadvertent forces imposed
thereon or due to dimensional changes or instability of the elastomeric
seal. Additionally, the vacuum or suction effect created as the prior
elastomeric tip cap is removed from the tip of the syringe barrel can
lead to the loss of medication and unnecessary personal contact with
medication that the tip cap is intended to avoid. Additionally, the prior
elastomeric tip cap provides no evidence of tampering or misuse of a
pre-filled syringe.

[0008] U.S. Pat. No. 6,190,364 describes a syringe tip cap for a syringe
body. The syringe body has a distal tip and a distal opening extending
through the latter, such that an injection liquid located in the syringe
body can exit the syringe body via the distal opening. The syringe
comprises a fastening ring, or luer collar, which is formed in one piece
with the syringe or is placed on the distal tip of the syringe body and
connected fixedly thereto. The fastening ring has thread elements which
interact with thread elements of a two-part closure cap in order to hold
the closure cap on the fastening ring. In use, the closure cap encloses
the distal tip and closes and seals off the distal opening of the syringe
body.

[0009] To inject the injection liquid, the closure cap is unscrewed from
the fastening ring and a syringe needle is secured on the fastening ring
and thus on the syringe body in such a way that a needle opening
extending through the syringe needle is in fluidic communication with the
distal opening of the syringe body. To secure the syringe needle on the
fastening ring, the syringe needle is connected to a thread element which
interacts with the thread element of the fastening ring.

[0010] To ensure that possible use of or tampering with the syringe
content is made evident, the syringe tip cap according to U.S. Pat. No.
6,190,364 comprises a sealing strip which is connected permanently both
to the fastening ring and also to the closure cap, such that the sealing
strip tears when the closure cap is detached from the fastening ring.

[0011] A disadvantage of the syringe tip cap known from U.S. Pat. No.
6,190,364 is that producing three separate parts (two-part closure cap,
sealing element) and joining these parts together to form a syringe tip
cap is an elaborate procedure.

[0012] US 2006/0178627 A1 discloses a syringe tip cap for sealingly
closing a distal opening of a syringe body. The syringe tip cap comprises
a fastening ring to be arranged and fastened on the syringe body about
the distal opening. A closure cap is releasably connected to the
fastening ring and closes the distal opening. The fastening ring has a
first locking device interlocked with a second locking device of the
closure cap. The first locking device and the second locking device are
configured not to be unlocked without sustaining damage. After unlocking,
the syringe tip cap cannot be returned to an initial locked state.

[0013] The German company Gerresheimer AG from Dusseldorf, is selling
syringe tip caps according to the caps known from US 2006/0178627 A1. The
practice has shown that it is possible to disengage the fastening ring of
the caps from the syringe body after opening of the syringe. After
disengaging the fastening ring, it is possible to lock the first locking
device with the second locking without sustaining damage. Afterwards, it
is possible to engage the fastening ring with the syringe body. As a
result, it is not possible to ensure that possible use of or tampering
with the syringe content is made evident.

[0014] Thus, there is a need for a cap assembly which would eliminate at
least one of the problems and limitations associated with the prior art
cap assemblies discussed above.

[0015] In order to solve one of the above mentioned problems, a cap
assembly according to the invention comprises a tip of a receptacle,
preferably a pre-filled receptacle.

[0016] Preferably, the tip is frangible and comprises a predetermined
breaking point. An upper portion of the tip closes the receptacle
respectively a lower tip portion comprising a passage as known from the
state of the art. Hence, the receptacle is reliably sealed to prevent
contamination or loss of the medication. Compared with the state of the
art, a receptacle has a more effectively sealed tip. It is necessary to
break the upper tip portion away in order to open the receptacle. A cap
element protects the tip on one side. On the other side, unscrewing the
cap breaks the upper portion away without hurting a person.

[0017] Typically, the receptacle is a syringe or a tube. As a rule, the
syringe or tube volume is up to 100 ml, preferably up to 30 ml.

[0018] In a preferred embodiment of the invention, the predetermined
breaking point is concave and borders on the upper angular edge of the
passage of the lower tip portion. As a result, breaking the upper tip
portion away cannot damage the angular edge of the passage.

[0019] In an embodiment of the invention, the tip of a cap assembly
comprises a plurality of projecting locking elements for attaching a
fastening ring like a luer collar. Due to the luer collar, it is possible
to screw a further cap element on the receptacle which may protect at
least an upper portion of the tip. The cap assembly according to this
embodiment may comprise an upper tip portion or a separate cap element
closing the opening of the receptacle.

[0020] The projecting locking elements may provide a plurality of
clearances in order to hold the fastening ring in appropriate manner.
Preferably, the clearances are so designed that it is not possible to
unfasten a fastening ring attached at the receptacle or at the tip
portion without sustaining damage. This embodiment of the invention is
suited for evidencing tampering or misuse of a pre-filled receptacle. On
the other hand, the projecting locking elements are so designed that it
is possible to fasten the fastening ring to the receptacle by a snapping
action as already known from the state of the art.

[0021] Preferably, the cap element is attached at the fastening ring by an
internal and an external thread or a bayonet joint. The cap element 13
comprises a plurality of locking tabs. In the closed position of the cap
assembly, the locking tabs are enclosed with a form fit by locking
recesses provided by projecting locking elements. The locking tabs and
the corresponding locking recesses or the projecting locking elements are
so designed that it is not possible to screw the cap element (13) on the
tip. In contrast to the state of the art, the cap assembly evidences
tampering or misuse of the syringe in all cases.

[0022] The various features, objects, benefits and advantages of the
present invention will become more apparent upon reading the following
detailed description of the preferred embodiment along with the appended
claims in conjunction with the drawings.

[0023] FIG. 1 shows an embodiment of the invention, a cap assembly 1
comprising a frangible tip of a receptacle 2. The receptacle may be a
syringe or a tube. The tip is composed of an upper tip portion 3, a lower
tip portion 4 and a predetermined breaking point 5 between the upper and
the lower tip portion. The tip is frangible due to the predetermined
breaking point 5. The lower tip portion looks like a hollow needle
comprising a canal 24. The tip is made in one piece and closes the
receptacle respectively the distal end of the canal 24. Breaking the
upper tip portion 3 opens the receptacle 2 respectively the distal end of
the canal 24. Hence, the upper tip portion acts as a closure of the
receptacle. Since the tip is made in one piece, it is impossible that the
closure of the receptacle comprises a leak or something like that. The
predetermined breaking point 5 is concave and borders on the upper
angular edge 6 of the lower tip portion 4. Breaking the upper tip portion
will not damage the upper angular edge 6. Hence, after opening the
receptacle there is an undamaged distal tip opening as known from a
syringe and the like.

[0024] The lower tip portion comprises a plurality of projecting locking
elements 7 adjacent at the body 2 of the receptacle. The projecting
locking elements 7 and the lower tip portion 4 are made in one piece. The
projecting locking elements 7 provide a plurality of clearances 8 for
attaching a fastening ring 9 to the receptacle respectively to the lower
tip portion 4. These clearances are between the projecting locking
elements 7 and the main body of the receptacle. The projecting locking
elements 7 are so designed that it is possible to fasten the fastening
ring 9 to the receptacle by a snapping action. However, it is not
possible to unfasten the fastening ring without sustaining damage. For
this reason, the angles between the lower side walls 10 of the projecting
locking elements 7 and the adjacent side wall of the lower tip portion 4
are 90° or smaller. The opposite side walls 11 of the projecting
locking elements 7 are inclined and act as ramp with regard to an annular
protrusion 12 of the fastening ring 9.

[0025] The annular protrusion 12 attaching the fastening ring to the
receptacle is inside of the fastening ring 9. The annular protrusion 12
and the fastening ring are made in one piece.

[0026] The cap assembly 1 comprises a cap element 13. The fastening ring 9
and the cap element 13 comprise interacting thread elements 14 and 15
which define a thread pitch. Due to the thread elements 14 and 15, it is
possible to open the receptacle by unscrewing the cap element 13. A
ring-like portion 16 of the cap element 13 is pressed against the upper
tip portion 3, acts as a seal and grips the upper tip portion 3.

[0027] For this reason, unscrewing of the cap element 13 breaks the
predetermined breaking point 5 and opens the receptacle. There is a
further ring-like portion 17 which is pressed against the lower tip
portion 4 acting as a seal. There remains a well-defined cavity 18
between the two seals 16 and 17. Hence, contamination of the lower tip
portion including the edge 6 within the well-defined cavity is not
possible.

[0028] Due to the conical profile of the lower tip portion 4 unscrewing of
the cap element 13 removes the lower ring-like portion 17 from the lower
tip portion at once. For this reason, the lower ring-like portion 17
cannot prevent unscrewing of the cap element 13.

[0029] The cap element 13 comprises a plurality of locking tabs 19. In the
closed position of cap assembly 1, the locking tabs 19 are enclosed with
a form fit by locking recesses 20. The locking recesses are provided by
the projecting locking elements 7. In contrast to the teaching known from
US 2006/0178627 A1, the locking tabs 19 and the corresponding locking
recesses will not irreversibly deformed or damaged by unscrewing the cap
element 13. As shown in FIG. 3, the locking tabs 19 and the corresponding
locking recesses 20 respectively the projecting locking elements 7 are so
designed that it is not possible to screw the cap element 13 on the tip 3
and 4. Due to the inclinations 21, it is possible to unscrew the cap
element 13. However, due to the stopping portions 22 and the tips 23 of
the projecting locking elements 7, it is impossible to screw the cap
element 13 on the tip of the receptacle 2.

[0030] A cylinder-like gap 25 remains between the cap element 13 and the
upper tip portion 3. The cylinder-like gap 25 extends to the seal 16 on
one side and to an opening 26 on the other side. It is possible to
evacuate the opening in order to check the operability of the seal 16. In
a similar way, it is possible to evacuate an opening 27 leading to the
seal 17 in order to check the operability of the seal 17.

[0031] The cap element 13 comprises a cylinder-like recess 28 surrounding
the upper tip portion 3. Due to the cylinder-like recess 28, it is
possible to grip the cap assembly 1 from the bottom for example by a
pinion 29 as shown in FIG. 4. It is then possible to fill the receptacle
with a medical preparation from the top according to the arrow 30 without
running into problems. In order to avoid a contamination, there is as a
rule a laminar gas flow in the direction of the arrow 30 during filling
the receptacle. For this reason, means for handling the receptacle in the
upper region during filling the receptacle are able to disturb the
process. Due to the cylinder-like recess 28, handling means in the upper
region are not necessary. After filling the receptacle 2, the
corresponding end will be closed for example by welding or a
corresponding method.

[0032] Preferably, the receptacle 2 as well as the cap assembly 1 are made
of plastic.

[0033] FIG. 5 shows the cap assembly 1 comprising a transparent fastening
ring 9. As a result, it is possible to see the position of the locking
tabs 19. The fastening ring 9 comprises a visible sign respectively a
visible mark. The cap element 13 comprises a corresponding visible sign
32. If the tips of the two signs 31 and 32 are in line as shown in FIG. 5
and if there is no visible gap between the cap element 3 and the
fastening ring 9, nobody tried to open the receptacle.

[0034] Providing the cap assembly 1 is very easy. At the beginning, the
cap element 13 will be screwed on the fastening ring 9. Afterwards, the
fastening ring 9 will be pushed against the corresponding end of the body
of the receptacle 2 thereby providing a snap-in connection between the
projecting locking elements 7 and the annular protrusion 12. Afterwards,
it is not possible remove the fastening ring 9 from the receptacle. For
this reason, it is not possible to close the receptacle by the cap
assembly 1 once again.